CD8 Minibody Repeatability Study

Melanoma Clinical Trial

— PRETZCEL  

Official title:

Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744128
• Other study ID #: IAB-CD8-204
• Status: Recruiting
• Phase: Phase 2
• Start date: February 16, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: March 2024
• Source: ImaginAb, Inc.
• Contact: Bronwen Williams
• Phone: +44 (0) 1482 462771
• Email: Bronwen.Williams[@]hyms.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and above

• Patients with at least one imageable primary or metastatic lesion > 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months

• Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy.

• Cohort 2: Patients with untreated renal cell carcinoma on active surveillance

• Women of child bearing potential must not be pregnant on study entry

• Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation.

Exclusion Criteria:

• Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator

• Patients with urinary catheters or stoma bags

• Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine

• Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded

• Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors

• Participant enrolled into another therapeutic intervention study

• Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator

• Women who are pregnant or breast feeding

• Unable to provide informed consent

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Melanoma
• Renal Cell Carcinoma

Intervention

Biological:
• Zirconium 89Zr crefmirlimab berdoxam
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Hull

Sponsors (2)

Lead Sponsor	Collaborator
ImaginAb, Inc.	University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVs in tumor	Absolute and relative difference in tumor SUVs	2-4 weeks
Primary	SUVs in reference tissues	Absolute and relative difference in reference tissue SUVs	2-4 weeks
Primary	ratio of tumor SUVs to reference tissue SUVs	Absolute and relative difference in SUV ratios	2-4 weeks
Secondary	Safety of repeat doses of Zr-89 crefmirlimab berdoxam	Adverse events collected during the trial and as self-reported events.	Through study completion, an average of 8 weeks